Package leaflet: Information for the user

Oxycodone Kalceks, 10 mg/ml, solution for injection/infusion
Oxycodone Kalceks, 50 mg/ml, solution for injection/infusion
oxycodoni hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Oxycodone Kalceks is and what it is used for
Important information before using Oxycodone Kalceks
How to use Oxycodone Kalceks
Possible side effects
How to store Oxycodone Kalceks
Contents of the pack and other information

1. What Oxycodone Kalceks is and what it is used for

This medicine has been prescribed by your doctor to relieve moderate to severe pain. The active substance is oxycodone, which has strong analgesic properties.
Oxycodone Kalceks is indicated for use only in adults.

2. Important information before using Oxycodone Kalceks

When not to use Oxycodone Kalceks:

if the patient is allergic to oxycodone or any of the other ingredients of this medicine (listed in section 6);
if the patient has hypersensitivity to morphine or other opioids;
if the patient has respiratory disorders, such as severe chronic obstructive pulmonary disease, severe bronchial asthma, or severe respiratory depression. These conditions must have been diagnosed by the treating physician. Symptoms may include shortness of breath, cough, or slower or weaker breathing than expected;
if the patient has heart disease diagnosed as cor pulmonale (heart changes due to chronic lung disease);
in cases of disorders such as abnormal intestinal function (small bowel obstruction) or severe abdominal pain;
if the patient has chronic constipation;
if the patient is under 18 years of age.

Warnings and precautions
Before starting treatment with Oxycodone Kalceks, discuss this with your doctor, pharmacist, or nurse:

in elderly or debilitated patients;
in patients with reduced thyroid gland activity (hypothyroidism), due to possible need for dose reduction;
in patients with myxedema, a thyroid disorder characterized by dry skin, lowered body temperature, and swelling (edema) of the facial and limb skin;
in patients with head injury, severe headaches, or nausea, as these may indicate increased intracranial pressure;
in patients with low blood pressure (hypotension);
in patients with reduced blood volume (hypovolemia), which may result from severe external or internal bleeding, severe burns, excessive sweating, severe diarrhea, or vomiting;
in patients with psychiatric disorders caused by infections (toxic psychosis);
in patients with pancreatitis (causing severe abdominal and back pain);
in patients with gallbladder or biliary tract dysfunction;
in patients with inflammatory bowel disease;
in men experiencing difficulty urinating due to enlarged prostate;
in patients with significantly impaired adrenal function (adrenal glands not functioning properly, causing symptoms such as weakness, weight loss, dizziness, vomiting, or nausea), e.g., Addison's disease;
in patients with breathing difficulties related to conditions such as severe lung disease. Such conditions must be confirmed by the treating physician. Possible symptoms include shortness of breath and cough;
in patients with kidney or liver disease;
in patients with a history of withdrawal symptoms such as agitation, anxiety, tremor, or sweating after stopping alcohol or drugs;
in patients with increased sensitivity to pain;
in patients requiring increasingly higher doses of Oxycodone Kalceks to relieve pain (tolerance).

Contact your doctor if the patient experiences severe upper abdominal pain radiating to the back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis or biliary tract inflammation.
Before any planned surgery, it is essential to inform the doctor about taking Oxycodone Kalceks.
Hormonal changes may occur during treatment with this medicine. The treating physician may decide to monitor these changes.

Tolerance, dependence, and abuse
This medicine contains oxycodone, which is an opioid. It may cause dependence and/or abuse.
This medicine contains oxycodone, an opioid analgesic. Repeated use of opioid painkillers may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to it, known as tolerance). Repeated use of Oxycodone Kalceks may lead to dependence, abuse, and addiction, which can result in life-threatening overdose. The risk of these adverse effects may be greater when higher doses are used over a longer period.
Dependence or addiction may cause the patient to lose control over how much medicine to take or how often to take it. The patient may feel a need to take the medicine even when it is not relieving pain.
The risk of developing dependence or addiction varies among individuals. The risk of addiction or dependence on Oxycodone Kalceks may be higher if:

the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or drugs ("addiction");
the patient is a smoker;
the patient has ever had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other psychiatric disorders.

If the patient notices any of the following symptoms while taking Oxycodone Kalceks, this may indicate developing dependence or addiction:

need to take the medicine longer than prescribed by the doctor;
need to take a higher dose than recommended;
use of the medicine for reasons other than prescribed, e.g., "to calm down" or "to help fall asleep";
repeated unsuccessful attempts to stop or reduce medicine use;
feeling unwell after stopping the medicine and improvement after restarting (withdrawal effect).

If the patient observes any of these symptoms, they should contact their doctor to discuss the best treatment plan, including the appropriate timing and safe method of discontinuation (see section 3 "Stopping Oxycodone Kalceks").

Sleep-related breathing disorders
Oxycodone Kalceks may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxemia (low blood oxygen levels during sleep). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices such symptoms, contact the doctor. The doctor may consider reducing the dose.

Oxycodone Kalceks and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Using this medicine together with certain other medicines may alter the effect of this medicine or other medicines.

Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if the treating doctor has prescribed benzodiazepines or related medicines together with opioids, the doctor should limit the dose and duration of concomitant treatment. Follow the doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. If such symptoms occur, contact the doctor.

The risk of adverse effects increases if the patient takes antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, causing the following symptoms in the patient: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, increased reflexes, increased muscle tension, and elevated body temperature above 38°C. If these symptoms occur, contact the doctor.

Inform your doctor or pharmacist if the patient is taking any of the following medicines:

medicines belonging to the group of monoamine oxidase inhibitors (MAOIs), including if the patient has taken such medicine within the last two weeks;
medicines that help with sleep or sedative medicines (e.g., anxiolytics, hypnotics, or sedatives);
medicines used to treat depression (such as paroxetine);
medicines used to treat psychiatric or mental disorders (such as phenothiazines or neuroleptics);
other strong painkillers;
muscle relaxants;
medicines used to treat high blood pressure;
quinidine (a medicine used to treat rapid heartbeat);
cimetidine (a medicine used to treat peptic ulcer disease, indigestion, or heartburn);
antifungal medicines (such as ketoconazole, voriconazole, itraconazole, and posaconazole);
antibiotics (such as clarithromycin, erythromycin, or telithromycin);
protease inhibitors used in the treatment of HIV infections (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
rifampicin (used to treat tuberculosis);
carbamazepine (a medicine used to treat epileptic seizures or convulsions and certain pain conditions);
phenytoin (a medicine used to treat epileptic seizures or convulsions);
the herbal remedy St. John's wort (also known as Hypericum perforatum);
antihistamines;
medicines used in the treatment of Parkinson's disease.

Also inform the doctor if the patient has recently undergone anesthesia.

Using Oxycodone Kalceks with food and alcohol
Drinking alcohol while taking Oxycodone Kalceks may cause drowsiness or increase the risk of adverse effects such as shallow breathing, with risk of respiratory arrest and loss of consciousness. Alcohol consumption should be avoided during treatment with Oxycodone Kalceks.
Avoid drinking grapefruit juice while taking Oxycodone Kalceks.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Data on the use of oxycodone in pregnant women are limited. Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Use of oxycodone during labor may cause breathing problems in the newborn.
Breastfeeding must be discontinued during treatment with Oxycodone Kalceks. Oxycodone passes into breast milk and may affect the health of the breastfed infant, especially after multiple doses.
Data on the effect of oxycodone on human fertility are not available.

Driving and operating machinery
This medicine may cause adverse effects such as drowsiness, which may affect the ability to drive and operate machinery (full information on adverse effects can be found in section 4). These are usually most noticeable when the medicine is first started or when the dose has been increased. If this applies to the patient, driving and operating machinery should be avoided.
Consult your doctor or pharmacist if you have any doubts about whether it is safe to drive while taking this medicine.

Oxycodone Kalceks contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml and is considered "sodium-free".

3. How to use Oxycodone Kalceks

The medicine will usually be prepared and administered by a doctor or nurse. The medicine should be used immediately after opening. The dose and frequency of administration may be adjusted according to the severity of pain.
Before starting treatment and regularly during ongoing treatment, your doctor will discuss with you what to expect from using Oxycodone Kalceks, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "Discontinuation of Oxycodone Kalceks").

Adults (over 18 years of age)
The initial dose depends on the route of administration. Recommended starting doses are as follows:

For single intravenous administration, the recommended dose is 1 to 10 mg administered slowly over 1–2 minutes. This may be repeated every 4 hours.
For intravenous infusion, the recommended starting dose is 2 mg per hour.
For single subcutaneous injection using a fine needle, the recommended starting dose is 5 mg, repeated every 4 hours as needed.
For subcutaneous infusion using a fine needle, the recommended starting dose is 7.5 mg per day.
For patient-controlled analgesia (PCA), the dose is calculated according to body weight (0.03 mg per kg body weight). Your doctor or nurse will determine the appropriate dosing frequency.

Children and adolescents
Oxycodone Kalceks must not be given to children and adolescents under 18 years of age.

Patients with hepatic or renal impairment
Inform your doctor if you have kidney or liver disease, as your doctor may recommend a lower dose depending on your condition.
Do not exceed the dose prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
If you continue to experience pain while taking this medicine, discuss it with your doctor.

Overdose of Oxycodone Kalceks
If you have taken more than the prescribed dose, contact your doctor immediately. In severe cases, overdose may lead to loss of consciousness or even death. Individuals who have received more than the recommended dose may experience drowsiness, nausea, or dizziness. They may also develop breathing difficulties leading to loss of consciousness and potentially death, requiring immediate hospital treatment. Overdose may result in brain damage (known as toxic leukoencephalopathy). When seeking medical help, bring this leaflet and any unused ampoules with you to show the doctor.

Discontinuation of Oxycodone Kalceks
Do not stop using Oxycodone Kalceks without consulting your doctor. If treatment with Oxycodone Kalceks is no longer necessary, it is recommended to gradually reduce the daily dose to avoid unpleasant withdrawal symptoms. Abrupt discontinuation may lead to withdrawal syndrome (symptoms: agitation, anxiety, palpitations, tremor, sweating).

If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
All medicines can cause allergic reactions, although severe allergic reactions are rare. You should contact your doctor immediately if you experience symptoms such as sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially if it spreads to the whole body.

The most serious adverse reaction is a condition in which the patient breathes more slowly or less deeply than normal (respiratory depression). You should contact your doctor immediately if this occurs.

As with all strong painkillers, there is a risk of dependence on this medicine.

Very common adverse reactions (may affect more than 1 in 10 patients)

constipation (your doctor may prescribe laxatives to help relieve this problem)
nausea or vomiting (these should resolve spontaneously within a few days, but your doctor may prescribe an antiemetic if symptoms persist)
drowsiness (usually occurs when starting treatment or after a dose increase, but should resolve spontaneously within a few days)
dizziness
headache
itching of the skin

Common adverse reactions (may affect up to 1 in 10 patients)

dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
confusion, depression, feeling unusually weak, tremor, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal thoughts or dreams
difficulty breathing or wheezing, shortness of breath, reduced cough reflex
rash
sweating

Uncommon adverse reactions (may affect up to 1 in 100 patients)

difficulty swallowing, belching, hiccups, flatulence, condition in which the intestine does not function properly (intestinal obstruction), gastritis, taste disturbances
dizziness or sensation of "spinning", hallucinations, mood changes, unpleasant mood, feeling of extreme happiness, motor restlessness, excitement, general malaise, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness of hands or feet, seizures, convulsions, blurred vision, fainting, unusual muscle stiffness or weakness, involuntary muscle contractions
difficulty urinating, impotence, decreased sexual desire, low levels of sex hormones in the blood (hypogonadism, observed in blood tests)
fast or irregular heartbeat, skin redness
dehydration, thirst, chills, swelling of the hands, ankles or feet
dry skin, severe peeling or shedding of the skin
facial flushing, constricted pupils, muscle spasms, high body temperature
need to take increasingly higher doses of this medicine to achieve the same level of pain relief (tolerance)
colicky abdominal pain or discomfort
impaired liver function (observed in blood tests)

Rare adverse reactions (may affect up to 1 in 1,000 patients)

low blood pressure
feeling faint, especially when standing up
itchy rash (urticaria)

Frequency not known (cannot be estimated from available data)

increased sensitivity to pain
aggression
sleep apnoea (pauses in breathing during sleep)
dental caries
absence of menstruation
blockage of bile flow from the liver (cholestasis). This may cause itching of the skin, yellowing of the skin, very dark urine and very pale stools
disorder affecting the valve in the intestines, which may cause severe upper abdominal pain (Oddi sphincter dysfunction)
prolonged use of Oxycodone Kalceks during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms observed in the infant include irritability, hyperexcitability and abnormal sleep patterns, high-pitched crying, tremors, vomiting, diarrhoea and failure to gain weight

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oxycodone Kalceks

The medicine should be stored out of sight and reach of children. This medicine must be stored in a closed and secure place inaccessible to others. It may be highly harmful and may cause death in a person for whom it has not been prescribed.
There are no special storage requirements for this medicine. Do not freeze.
Shelf life after first opening:
After opening, the medicine should be administered immediately.
Shelf life after dilution:
Chemical and physical stability has been demonstrated for 24 hours at 25°C and at 2–8°C (after dilution with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) glucose solution, or water for injections).
From a microbiological standpoint, the medicine should be administered immediately after dilution.
If the medicine is not used immediately, the responsibility for the duration and conditions of storage prior to use lies with the user; however, this period should generally not exceed 24 hours, provided the solution is stored at 2–8°C, unless the dilution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if any signs of deterioration are observed (e.g. presence of particles in the solution).
Do not use this medicine after the expiry date stated on the label and carton after: (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oxycodone Kalceks contains
Oxycodone Kalceks 10 mg/ml:

The active substance is oxycodone hydrochloride. One 1 ml ampoule contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg of oxycodone). One 2 ml ampoule contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg of oxycodone).

Oxycodone Kalceks 50 mg/ml:

One 1 ml ampoule contains 50 mg of oxycodone hydrochloride (equivalent to 45 mg of oxycodone).

Other ingredients: citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Oxycodone Kalceks looks like and contents of the pack
A clear, colourless solution for injection/infusion, free from visible particles.
Oxycodone Kalceks is available in colourless glass ampoules of 1 ml and 2 ml, packed in a cardboard carton.
The ampoules are marked with a special colour-coded ring, different for each strength and volume.

Pack sizes:
Oxycodone Kalceks 10 mg/ml
5, 10 or 25 ampoules of 1 ml
5 or 10 ampoules of 2 ml

Oxycodone Kalceks 50 mg/ml
5 or 10 ampoules of 1 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
1057 Rīga, Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Estonia Oxycodone Kalceks
Germany Oxycodon Ethypharm Kalceks 10 mg/ml Injektions-/Infusionslösung
Oxycodon Ethypharm Kalceks 50 mg/ml Injektions-/Infusionslösung
Denmark Oxycodone Kalceks
Finland Oxycodone Kalceks
France OXYCODONE KALCEKS 10 mg/mL, solution injectable/pour perfusion
OXYCODONE KALCEKS 50 mg/mL, solution injectable/pour perfusion
Ireland Oxycodone Hydrochloride 10 mg/ml, 50 mg/ml solution for injection/infusion
Lithuania Oxycodone Kalceks 10 mg/ml, 50 mg/ml injekcinis ar infuzinis tirpalas
Latvia Oxycodone Kalceks 10 mg/ml, 50 mg/ml šķīdums injekcijām/infūzijām
Netherlands Oxycodon Kalceks 10 mg/ml, 50 mg/ml oplossing voor injectie/infusie
Norway Oxycodone Kalceks
Poland Oxycodone Kalceks
Sweden Oxycodone Kalceks
United Kingdom (Northern Ireland)
Oxycodone Hydrochloride 10 mg/ml solution for injection/infusion
Oxycodone Hydrochloride 50 mg/ml solution for injection/infusion

Information intended exclusively for medical professionals:

Dosage
Dosage should be adjusted according to the intensity of pain, the patient's general condition, and previously or currently used medications.

Adults over 18 years of age
The following initial doses are recommended. Gradual dose escalation may be necessary if analgesic effect is insufficient or if pain intensity increases.

Intravenous, iv. (bolus): The solution should be diluted to 1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or in water for injections. Slow intravenous injection (bolus) of 1–10 mg oxycodone hydrochloride over 1–2 minutes is recommended. Doses should not be administered more frequently than every 4 hours.

Intravenous, iv. (infusion): The solution should be diluted to 1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or in water for injections. The recommended initial dose is 2 mg per hour.

Intravenous, iv. (PCA): The solution should be diluted to 1 mg/ml in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or in water for injections. A dose of 0.03 mg/kg body weight administered as a slow intravenous bolus with a minimum refractory period of 5 minutes is recommended. (PCA – patient-controlled analgesia).

Subcutaneous, sc. (bolus): Use a concentration of 10 mg/ml. Oxycodone Kalceks 50 mg/ml must be diluted in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or in water for injections. The recommended initial dose is 5 mg, which may be repeated every 4 hours.

Subcutaneous, sc. (infusion): If necessary, the solution should be diluted in 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or in water for injections. An initial dose of 7.5 mg/day is recommended for opioid-naïve patients. The dose should be gradually increased according to symptoms.

Cancer patients who are being switched from oral oxycodone to parenteral oxycodone may require significantly higher doses (see below).

Switching from oral to parenteral oxycodone:
The following conversion ratio may be used to determine dosage: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is an approximate guideline. Due to inter-individual differences, the appropriate dose must be individually titrated. The patient should be closely monitored until a stable condition is achieved after changing the opioid formulation.

Switching from intravenous morphine to intravenous oxycodone:
In patients previously receiving intravenous morphine, the daily dose of intravenous oxycodone should be determined based on a 1:1 equivalence ratio. It should be emphasized that this is only a guideline. Due to inter-individual differences, the appropriate dose must be individually titrated. The patient should be closely monitored until a stable condition is achieved after changing the opioid formulation.

Elderly patients
Treatment in elderly patients should be initiated with caution. The lowest possible dose should be administered and carefully increased to control pain.

Patients with renal or hepatic impairment:
In these patient groups, initial dosing should be conservative and cautious. The recommended initial dose for adults should be reduced by 50% (e.g., total daily dose of 10 mg orally in opioid-naïve patients). The effective dose should then be individually assessed and adjusted according to the patient's clinical situation (see section 5.2).

Children and adolescents
There are no data on the use of injectable oxycodone in patients under 18 years of age.

Use in non-malignant pain:
Opioids are not first-line treatment for chronic non-malignant pain and are not recommended as the sole treatment method. Chronic pain types for which strong opioids have demonstrated efficacy include chronic pain due to degenerative joint disease and intervertebral disc disease. The continued need for treatment of non-malignant pain should be regularly reassessed.

Endocrine system:
Opioids may affect the hypothalamic-pituitary-adrenal axis or gonadal function. Some observed changes include increased serum prolactin levels and decreased plasma cortisol and testosterone levels. These hormonal changes may lead to clinical symptoms.

Concomitant therapy:
Enhanced central nervous system (CNS) depressant effects may occur, potentially leading to profound sedation, respiratory depression, coma, and death, when opioids are used concomitantly with benzodiazepines or other CNS-active drugs such as tranquilizers, anesthetics, hypnotics, antidepressants, non-benzodiazepine sedatives, phenothiazine derivatives, neuroleptics, alcohol, other opioids, muscle relaxants, and antihypertensive agents.

Duration of treatment:
Oxycodone should not be used longer than necessary.

Discontinuation of treatment:
When a patient no longer requires oxycodone therapy, gradual dose reduction may be indicated to prevent withdrawal symptoms.

Route of administration
Subcutaneous injection or infusion.
Intravenous injection or infusion.

Pharmaceutical incompatibilities
Cyclizine at concentrations of 3 mg/ml or lower, when mixed with Oxycodone Kalceks either undiluted or diluted with water for injections, does not cause precipitation over a 24-hour storage period at room temperature. Precipitation has been observed in mixtures of injectable oxycodone with cyclizine at concentrations exceeding 3 mg/ml or when diluted with 9 mg/ml (0.9%) sodium chloride solution.
However, if the dose of Oxycodone Kalceks is small and the solution is sufficiently diluted with water for injections, concentrations higher than 3 mg/ml may be used. Water for injections is recommended as a diluent when cyclizine and oxycodone hydrochloride are administered simultaneously via intravenous or subcutaneous infusion.

Prochlorperazine is chemically incompatible with Oxycodone Kalceks.

Instructions for use and storage
Each ampoule is intended for single use in one patient only. The product should be used immediately after opening the ampoule, and any unused residue should be discarded. Do not use if any signs of deterioration are visible (e.g., particulate matter).

Chemical and physical stability has been demonstrated for 24 hours at 25°C and at 2–8°C.
From a microbiological standpoint, the solution should be used immediately after dilution. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user. Generally, the storage period should not exceed 24 hours if the solution is stored at 2–8°C, unless dilution was performed under controlled and validated aseptic conditions.

Oxycodone Kalceks 10 mg/ml, either undiluted or diluted to a concentration of 1 mg/ml with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injections, and Oxycodone Kalceks 50 mg/ml, either undiluted or diluted to a concentration of 3 mg/ml with 9 mg/ml (0.9%) sodium chloride solution, 50 mg/ml (5%) dextrose solution, or water for injections, is physically and chemically stable in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags for 24 hours at room temperature (25°C) and at 2–8°C.

Oxycodone Kalceks, both undiluted and diluted in infusion fluids used in these studies and contained in various sets, does not require protection from light.

The product is also compatible with the following drugs: butylscopolamine bromide, hyoscine hydrobromide, sodium phosphate of dexamethasone, haloperidol, midazolam hydrochloride, metoclopramide hydrochloride, levomepromazine hydrochloride, glycopyrronium bromide, ketamine hydrochloride.

Improper handling of the undiluted product after opening the ampoule, as well as of the diluted solution, may compromise the sterility of the product.

Oxycodone kalceks